DRAFT  
 
No. ______date_________  
 
ON MEDICAL DEVICES IN THE REPUBLIC OF ALBANIA  
 
 
In accordance with Article 81, Clause 1 of the Constitution of the Republic of Albania, 
with the proposal of the Council of Ministers  
 
THE ASSEMBLY  
 
OF THE REPUBLIC OF ALBANIA  
 
DECIDED:  
 
 
CHAPTER I  
 
GENERAL PROVISIONS  
 
Article 1  
Scope  
 
This law is intended to provide a high level of safety and health protection towards the 
patients, users and third parties, as well as to preserve the levels of effectiveness of 
medical devices p rovided by the manufacturer.  
 
Article 2  
Field of application  
 
1. This law provides for requirements on:  
 
a. Medical devices and accessories (hereinafter referred to as medical devices) and  
   their production;  
b. Launching medical devices and their impl ementation on the market;  
c. Provision of clinical assessments on medical devices;  
d. Professional users of medical devices.  
 
2. This law is not applicable for users, manufacturers, the launch and  
    the availability of the following products:  
 
a. Cosme tic products;  
b. Personal protective equipment;  
c. Transplant of tissue or cells of human origin and products incorporated          or derived from tissue or cells of human origin;  
 
c. Transplant of tissue or cells of animal origin, other than products  
     manufactured from lifeless or rendered lifeless animal tissue;  
 
e. Medical devices of in vitro diagnostics.  
 
Article 3  
Definitions  
 
1. “medical device”  is any instrument, apparatus, material or any other means, 
utilised either alone or combined, also in cluding the required program for the 
accurate use and with the primary purpose of the manufacturer regarding human 
waste and with the purpose of:  
 
- diagnostics, prevention, monitoring, treatment or soothing of the illness,  
- diagnostics, monitoring, treat ment or soothing or compensation of an injury or    
   disability,  
- investigation, replacement or modification of the anatomy or the physiological 
process,  
- control of conception  
and those that cannot be used according to the primary purpose on the huma n 
body by pharmacological, immunological or metabolic means, but that may be 
aided to function by such means;   
 
2. “Accessory”  is a means which, when not classified as a device, is intended to be 
used by the manufacturer as an attachment to a device that ena bles it to function 
in accordance with the device usage from the device manufacturer;  
3. “Actively implanted medical device”  is a medical device that, in order to function, 
is supported by an electrical power source or a power source other than the one 
produ ced directly from the human body, or gravity, and that is partially or 
completely inserted inside the human body by surgical means or not, or by a non -
surgical intervention inside a natural gap, and is intended to stay there following 
the procedure;  
4. “In v itro diagnostic medical device”  is any medical device that is a reagent, 
reactive, calibrating product, control material, tool, instrument, apparatus, means 
or system, used either alone or combined, intended to be used in vitro by the 
manufacturer for the examination of the samples, including the donation of blood 
and tissue taken from the human body, intended solely or mainly for the provision 
of information regarding:  
—  physiological or pathological condition, or  
—  congenital abnormality , or 
— to establ ish safety and compatibility with possible receivers, or  
— to monitor therapeutic measures.  
 Sample receivers  are considered to be in vitro diagnostic medical devices. 
‘Sample receivers’ are such devices, either of the vacuum type or not, which are 
produc ed by the manufacturer with the only scope of keeping and preserving 
samples taken from the human body intended for in vitro diagnostic examinations.  
 
Products for general laboratory use  are not in vitro diagnostic medical products, 
unless these products,  depending on their characteristics, are produced by the 
manufacturer for the only intended use of in vitro diagnostic examination;  
 
5. “ordered device”  is any device manufactured in accordance with the written 
order of a qualified  physician, who gives, withi n the realm of his responsibilities, 
specific manufacturing characteristics and is intended to be used on a particular 
person. The aforementioned order may also be released by other authorized 
persons, based on his qualifications to do so. Mass produced de vices that need to 
adapt in order to meet the specific requirements of the physician or any other 
professional user, are not considered to be ordered devices;  
6. “device that is subject to clinical investigation”  is a medical device that is 
clinically investi gated by a professional user;  
7. “User of medical devices”  is one who uses the medical device without the 
supervision of a health care provider, who is termed ordinary user of medical 
devices, or a person who uses a medical device to obtain clinical facts in  the 
process of providing health care service and in studies, science or research, 
termed a professional user;  
8. “intended use of the medical device”  is the intended use of the device, in 
accordance with the data presented by the manufacturer on labelling, i n the 
instructions and/or promotional materials;  
9. “The launch”  is making a device available for the first time, by payment or not, 
other than a device designed for clinical investigation, intended to be delivered 
and/or used in the local market, regardless if it is new or completely 
reconditioned;  
10. “availability”  is the stage at which a device is made available to the end user,  
being ready for use for the first time in the local market for its intended purpose;  
11. “authorized representative”  is any natural or l egal person, established within the 
territory of the Republic of Albania which, clearly designated by the 
manufacturer, acts in the name and on behalf of the manufacturer. Country 
National authorities and organizations communicate with the authorised 
repre sentative instead of the manufacturer regarding the rights of the 
aforementioned;  
12. “Undesirable event”  with the medical device is an accident and/or incident that 
causes or has the potential to cause unexpected or undesirable  effects concerning 
the safety o f patients, users or other persons that occur whilst using the medical 
device.  
 
 
 
CHAPTER II   
THE PRODUCTION AND LAUNCH OF THE DEVICE  
 
Article 4  
Responsibility of the Manufacturer  
 
1. The manufacturer is responsible for designing, manufacturing, packaging and labelling 
of a medical device, regardless of whether these actions are performed by this person 
himself or in his name by a third party.  
2. The obligations of this law that must be met by the manufacturers also serve for the 
person who collects, packag es, processes, fully reconditions or labels one or more 
finished products, or assigns them for their designated purpose as a device, with the scope 
of launching it under his name.  
3. The first paragraph of this article is not applicable to the person who a ssembles or 
adapts devices that are already on the market for their intended purpose for a specific 
patient.   
 
Article 5  
Launch and Availability  
 
1. The medical devices will be launched and/or made available only if they meet the 
stated requirements in this Law, when they are properly equipped, installed, 
maintained and used in accordance with their designated purpose.   
2. The Minister of Health determines the conditions and the procedure for the 
notification of introducing the medical devices on the market and  for performing 
important modifications to medical devices.  
 
Article 6  
Requirements for the Launch and Availability of Medical Devices  
  
1. A medical device is launched and is made available only if:  
 
a. the device meets the requirements of this law and r egulations in its application;  
b. clinical assessment is provided for this device and if necessary, clinical 
investigation of the device has been performed;  
c. conformity assessment of the device has been performed;  
d. the device is accompanied by the app ropriate information, necessary to the 
identification of the manufacturer and for the safe use of the device for the 
intended purpose.  
 
 
2. The Minister of Health has the right, if an explicit request for this purpose has 
already been proposed, to allow the l aunch and the use of specific medical 
devices, the conformity of which has not been assessed, under the condition that 
the use of such devices is absolutely necessary for public health protection.  
 3. The medical devices that emit ionizing radiation, besides the requirements of this   
law, should also meet the requirement of Law No. 7870, date 13/10/1994 “On 
ionizing radiation”, as amended.  
 
4. When a medical device within its structure has, as an inseparable part, a material which   
if used separately, may b e called a medical product, in addition to the requirements of 
this law, requirements of other acts for the medical products are also applicable.  
  
5.  In order to guarantee the safety of gas pipes that provide medical gas to health care 
services, in addit ion to the requirements of this law, requirements of other acts for the 
safety of devices under pressure also apply.  
 
6. The basic information regarding the safe use of a medical device for the intended 
purpose, that accompanies a medical device that will  be launched and used in Albania, is 
provided in the Albanian language and in the correct form, taking into consideration the 
required knowledge from the potential users of the device. Other remaining 
accompanying information can be introduced in another l anguage of another member 
state of the European economical zone, understood by any potential user.  
 
Article 7  
Requirements for the Medical Device  
 
 1. A medical device is designed, manufactured, packaged and labelled so that:  
 
a. when a medical device rea ches the intended form by the manufacturer, its use is 
guaranteed for the purpose of which it is manufactured;.  
b. if properly installed and used under the prescribed conditions, the device does not 
cause the deterioration of the quality of treatment, does  not present a risk on life, health 
or the property of the patient, ordinary user or of a third person;  
c. the benefit regarding the health of the patient needs to be greater than the possible risks  
    regarding the use of the device;  
 
2. By the Decision  of the Council of Ministers, the requirements on designing, 
manufacturing and packaging of medical devices and the information that accompanies 
the medical devices, are determined.  
 
 
Article 8  
Introduction of Medical Devices that Fail the Conformity Test  
 
A medical device that fails to pass the conformity test can be presented in fairs or other 
commercial events, on the condition that the medical device should be accompanied by 
clearly visible information stating that the device should not be launched or operated until 
it complies with the requirements specified in this Law and in the legislation created in 
accordance with it.  
  
 
CHAPTER III  
 
CLASSIFICATION AND REGISTRATION OF MEDICAL DEVICES  
 
Article 9  
Classification of Medical Devices  
 
1. In order to en able the implementation of the necessary procedures of the conformity 
assessment, a manufacturer is asked to classify the medical devices. Their differentiation 
is done in categories based on the possible risk that the device presents to the life and 
healt h of people and to the primary purpose of the manufacturer.  
 
2. The medical devices, besides in vitro diagnostic medical devices and actively  
implantable medical devices, are organised into four categories: I, IIa, IIb and  III.  
 
3. In vitro diagnostic m edical devices are classified as:  
a. medical devices that present a low risk to the patient;  
 b. medical devices that present risk to the patient.  
 
4. Medical devices specified in clause 3.b of this article are divided into list A  
    and list B devices.   
 
5. Actively implantable medical devices are not classified and they are assessed  
    as medical devices that present risk.  
 
6. The Council of Ministers determines regulations regarding the classification of medical 
devices.  
 
7. If the manufacturer and t he notified body do not agree on the proper implementation of 
the classification regulations, the case is directed to the State Agency of Medical Devices 
who decides on the classification of the device.  
 
 
Article 10  
State Agency of Medical Devices  
 
1. The Sta te Agency of Medical Devices is the accredited authority in the field of 
clinical engineering, supporting Albanian health care with the proper 
infrastructure of the technology for the medical devices.  
2. The structure and its way of functioning is regulated by the Decision of the 
Council of Ministers.  
 
 
 Article 11  
The Notifying Body  
 
1. The notifying body is the organisation assigned by the Ministry of Health for 
performing the conformity assessment procedures of the medical devices.  
2. The Ministry of Health noti fies the European Commission and member states of 
the European economical zone regarding the notifying body that has been 
assigned.  
3. The criteria for recognising the notifying body by the Ministry of Health are 
determined by Decision of the Council of Minis ters.  
 
Article 12  
A person who acts as a notified body, allows the State Agency of Medical Devices to 
look at the documents that have information on:  
 
a. qualifications of the contractors and the activities performed by the contractors in 
accordance with  this law;  
 b. economical activities of notified bodies.  
  
Article 13  
Clinical Assessment of Medical Devices  
 
1. The manufacturer provides a clinical assessment of the medical device before 
performing the conformity assessment to verify the conformity of a m edical 
device with the specified requirements stated in article 7 of this law for the 
intended purpose and to determine any undesirable side effects that are caused by 
the medical device.  
2. The clinical assessment of the actively implemented medical device a nd group III 
of medical devices is provided by the clinical information. The clinical 
information is based on the drafting of scientific and technical information 
regarding the use according to the intended purpose of the medical device and 
depending on th e case, a written report that contains the critical assessment of this 
draft.  
3. The persons involved in providing the clinical assessment guarantee the 
confidentiality of the information.  
 
 
Article 14  
Clinical Investigation of Medical Devices  
 
1. The clinica l investigation of the medical device is performed for the following 
purposes:  
 
a. to verify that the performance of the device in normal usage conditions  
    complies to the requirements specified in article 7 of this law.  b. to determine any undesirable side effect in normal usage conditions and to 
assess whether the medical device consti tutes risk when presented to it s intended 
purpose.  
 
2. It is the responsibility of the manufacturer or the authorised representative to perform 
the clinical investigation . Besides the manufacturer or its authorised representative, the 
clinical investigation is also the responsibility of the professional user.  
  
3. The manufacturer or his authorised representative guarantee the State Agency of  
    Medical Devices the righ t to use this written report of clinical investigation,  
    signed by the professional user who performs the investigation, which should contain            
    the critical assessment of all data collected during the clinical investigation.  
 
4. The informati on regarding the clinical investigation is confidential.  
 
5. The Minister of Health defines the regulation for the procedure of performing the 
clinical investigation of the medical devices.  
 
 
Article 15  
Exercising the Right to Perform Clinical Investigation o f the Medical Device  
 
1. In order to perform a clinical investigation of a clinical device, the manufacturer or his 
authorised representative gets the approval of the Ministry of Health regarding clinical 
tests in accordance with the procedures and terms d efined in the Regulation issued by the 
Minister of Health.  
2. The manufacturer or his authorised representative present a written request for     
performing a clinical investigation at the State Agency of Medical Devices. The request  
contains information on: 
a. identification of the medical device that will be investigated;  
b. time of investigation;  
c. the approval of the Ministry of Health regarding clinical tests;  
d. the name of the professional user performing the investigation and the name of 
the perso n responsible for the investigation;  
e. the place, the date of commencement and the specified duration of the 
investigation;  
f. the declaration that, besides the aspects on which the medical device is being 
investigated, meets the requirements specified in  article 7 of this law;  
g. the declaration that all protective measures regarding the health and safety of 
the patient have been taken for the purpose of the medical device under 
investigation.  
 
3. The State Agency of Medical Devices provides permission f or the organisation of the 
clinical investigation  
    of the medical device or denies such permission based on the principles of protecting     
   the health of the person and maintaining public order within:  a. 90 days after the date of receiving all nec essary documentation in the case of 
the actively implanted medical device, the medical device of group III or group II 
a or II b that are manufactured for long -term use;  
b. 30 days after the date of receiving all necessary documentation in the case of all 
other medical devices.  
 
4. This article is not applicable for the medical devices that have the CE mark of 
conformity, except in the case of the investigation being performed regardless of the 
intended purpose of the device.  
5. The presented information re garding the clinical investigation is confidential.  
 
 
 
Article 16  
Conformity Assessment of Medical Devices  
 
1. A person who wishes to launch a medical device in his name, verifies that the 
manufactured device complies to its specific requirements by the co nformity assessment. 
Following this verification, the person prepares a conformity declaration and places the 
CE mark of conformity on the medical device. The CE mark is not placed on medical 
devices subject to clinical investigation, medical devices made by order and medical 
devices for performance assessment.  
2. After performing the conformity assessment, the notifying body issues a conformity  
certificate or an appendix for the certificate verifying the conformity of the medical 
device or the quality sys tem. 
3. The notifying body has the right to suspend or void the conformity certificate if the 
person specified in clause 1 of this article does not meet or ceases to meet the 
requirements of this Law or the legislation created in accordance with it, or if the 
conformity certificate should not have been issued. The conformity certificate is not 
suspended or made void if the manufacturer has implemented measures that eliminate the 
lack of conformity.  
4. The procedure for the conformity assessment of the medi cal device is determined by  
    Decision of the Council of Ministers.  
 
 
Article 17  
 
In the case of non -conformity of the medical device to the requirements of this Law and 
to the legislation developed in its application, the State Agency of Medical Devic es will 
commence a supervising procedure with the scope of withdrawing this device from the 
market, inhibition or res triction of launching it and it s availability. The State Agency of 
Medical Devices immediately informs the European Commission and the accr edited 
authorities of the European Economical Zone for the commencement of a s upervising 
procedure and for it s performance and result.   
 
  
 
 
Article 18  
Systems for Medical Devices and Packages  
 
1. Any person who collects/assembles the device with the CE m ark in accordance with 
their intended purpose and in accordance with the usage limits specified by their 
manufacturers, will draft a declaration with the purpose of launching them as a system or 
package, stating that:  
 
a. he has verified the reciprocal com pliance of the devices in accordance with  
    the instructions of the manufacturers;  
b. he has acted in accordance with these instructions;  
c. he has packed the system or the package and has provided relevant information 
on the users including the relevan t instructions from the manufacturers;  
d. all the activity of collecting the devices has undergone suitable methods for 
inside control and inspection.  
 
2. If the terms specified in clause 1 of this article are not fulfilled, as in cases when the 
system or the package includes devices that do not have the CE mark or when the chosen 
combination of the devices does not conform to their initial intended use, the system or 
the package wi ll be treated as a device in it s own right and as such will be subject to th e 
conformity assessment procedure of the medical devices in accordance to this law.  
 
3.  Any person who has sterilised the aforementioned systems stated in the first paragraph 
of this article, or other medical devices that have the CE mark, designed by the  
manufacturers to be sterilised before use, with its solution, will follow the conformity 
assessment procedure suitable for the scope of obtaining sterility. The person who 
sterilises a device, drafts a declaration stating that the sterilisation is conduct ed in 
accordance with the instructions of the manufacturer.  
 
4. The information that accompanies the products specified in the first and the third  
paragraph of this article includes information on any assembled device.  
 
5. The persons specified in clause s 1 and 3 of this article will retain the declarations in 
order that they can be made available to the State Agency of Medical Devices, if 
required, for a 5 -year period following the date of their provision.  
 
 
 
 
 
 
Article 19  
Reporting and Investigating Un desirable Events   
1. The Ministry of Health undertakes all the necessary steps to ensure that information 
can be obtained relating to any malfunction or damage/destruction of the characteristics 
and/or functioning of the medical device, technical factors r elated to them, as well as the 
unsuitability in labelling or instructions that:  
a. have led, may lead, might lead or might have led to the death of a patient, of a 
third person, of an ordinary user, to the deterioration of a patient’s health 
condition;  
b. deal with the damage of the characteristics and/or functioning of a type of  
medical device that has been continuously acknowledged by the manufacturer.  
2. Every health care institution immediately notifies the State Agency of Medical Devices 
and the man ufacturer regarding the circumstances specified in clause 1 of this article.  
3. The manufacturer or his authorised representative informs the State Agency of Medical  
Devices for any undesirable event that happens during clinical investigation of a medica l 
device.  
4. A distributor of medical devices immediately informs the manufacturer of the medical 
device or his authorised representative for any undesirable event that could have been 
caused by a malfunction or damage of the characteristics and/or functi oning of this 
device.  
5. The State Agency of Medical Devices investigates the circumstances in which the 
undesired event happened and if possible, seeks the assistance of the manufacturer for 
this purpose.  
6. After performing the assessment of the event, the State Agency of Medical Devices 
informs the following bodies on the process, investigation results and the relevant 
measures taken or considered: the institution where the event happened, the other 
institutions where it is assessed, the manufacture r or his authorised representative, the 
notifying body when it is involved in the conformity assessment of the medical device in 
relation to the undesirable event.  
7. The persons that give information regarding the undesirable event, guarantee the 
protection of the personal information of the patient or ordinary user and the confidential 
information of the business that is made available in the process of investigating the 
undesirable event.  
8. The State Agency of Medical Devices immediately informs the Europ ean Commission 
and the accredited authorities of the European Economical Zone member states about the 
undesirable event related to a supervising procedure that has commenced with the 
purpose of withdrawing such a device from the ma rket, or to stop or restr ict it s launch 
and its availability.  
The State Agency of Medical Devices in this notification defines whether the event is 
caused by failure to meet the requirements, the incorrect application of harmonised 
standards or unsuitability of the harmonised stan dards.  
8. The Minister of Health defines the procedure and the format of the report for  
   undesirable events.  
 
 
Article 20  
Retention of Documents for Medical Devices   
1. The manufacturer of a medical device, within five years from the production date of  
the last device of that particular type, allows the State Agency of the Devices to use the 
following documents that accompany the medical device:  
 
a. declaration of conformity of the medical device;  
b. the request that is presented to the notified body fo r the conformity assessment of the 
quality system;  
c. the documents that describe the model, the production and the functioning of the 
medical device that enables the conformity assessment of the device;  
d. the documents issued by the notifying body and th e prepared reports during the 
inspection of the manufacturer;  
e. the standard certificate of the examination.  
 
Article 21  
Database of Medical Devices, Persons Launching the Medical Devices and the 
Undesirable Events  
 
1. The database of medical devices, pe rsons launching the medical devices and of the 
undesirable events is a database of State Agency of Medical Devices.  This database 
summarises:  
1) the data that identifies the medical devices defined in Article 1. The 
notification of launching the medical device, the provision of the information on 
medical devices that are on the market and the persons that launch them, 
including a special notification if the blood products are used in a device;  
2) the undesirable events and the circumstances in which they  occurred as 
specified in Article 19, “Reporting and investigating undesirable events” of this 
Law;  
3) the information on certificates of conformity issued by the notified bodies.  
 
2. The State Agency of the Medical Devices is the authorised processor an d the main 
processor of the database of medical devices, the person that launches the medical 
devices on the market and the undesirable events.  
3. The database defined in clause 1 of this article is provided to the European database of 
medical devices and  to any accredited authority of the European Economical Zone 
member states.   
 
 
 
 
 
 
 
 
CHAPTER IV  
 PROFESSIONAL USE OF MEDICAL DEVICES  
 
Article 22  
Requirements for Health Care Provider Institution on the Professional Use of 
Medical Devices  
 
 1. A medical dev ice is used in a professional manner solely for its intended purpose in 
accordance with the manufacturer’s instructions, taking into consideration the principles 
of medicine based on facts when, after investigating case by case the possible efficiency, 
the benefit and the alternative less harmful risks that serve the same purpose, it is noticed 
that the benefit for the patient’s health is much higher than the possible risks in the use of 
the device.  
2. The owner of a medical device guarantees:  
1) the exis tence of the conditions required for the use of medical devices, 
according to the definitions described by the manufacturer;  
2) the existence of instructions for the use of the device in the place where it is   
      used;  
3) the performance of installat ion and maintenance and when necessary, the 
reparation services from a competent person.  
 
 Article 23  
Premises for Medical Devices  
1. Before initiating the use of a medical device, the health care provision institution 
checks the technical conditions of t he medical device and takes measures for the training 
of professional users, on the condition that these requirements are applicable for the 
medical device that is being operated.  
2. In cases when the verification for the correct and safe functioning of a  medical device 
is needed in order to be operated, the health care provision institution must prepare a 
report on the operation of the medical device.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CHAPTER V  
 STATE SUPERVISION  
   
Article 24  
The Competence of the State Supervision Author ities 
 
The state supervision for the compliance of the requirements defined by this Law and the 
legislation developed in its application, is exercised by the Ministry of Health and by the 
State Agency of Medical Devices.   
 
 
Article 25  
The Rights and Oblig ations of Operators Exercising State Supervision  
 
1. The clerk who exercises the state supervision has the right to:  
   
a. inspect the adherence of the requirements of this law and of the legislation 
developed in its application without obstruction and wit hout prior notice;  
b. enter, for the purpose of supervision, inside the premises of a person who is 
subject to inspection, in the presence of the person subject to inspection, the 
representative or his employee.  
c. obtain the necessary information for the  supervision, to inspect the relevant 
documents fo r the supervision along with it s copies and to obtain copies of them;  
d. decide on the interventions that need to take place.  
 
2. The clerks that exercise state supervision guarantee the confidentiality o f the business 
and of the technical information they obtain, except in the cases when the declaration of 
this information is provided by law;  
3. A person subject to the supervision should help the person that exercises it in the 
execution of the duties pr ovided by law and the legislation developed in its application.  
4.  The manufacturers of medical devices that are subject to clinical investigation or those 
medical devices made to order, provide the possibility to the State Agency of Medical 
Devices to i nspect the documents that enable the conformity assessment of the medical 
devices in accordance with the requirements of this law and legislation developed in its 
application:  
a) documents regarding the production, functioning and the expected effect of a  
device made to order;  
b) the general description of the medical device subject to clinical investigation, 
relevant projects and production methods, necessary explanations regarding the 
projects and the functioning of the devices, the results of the risk analysis, the 
results of the performed test and a list of harmonised standards observed. If the 
harmonised standards are not observed as a whole, there should be a description 
provided of the measures guaranteeing the conformity to the requirements of this  
law and of the legislation developed in it s application.  
c) documents regarding the production, functioning and the expected effect of a 
medical device for the assessment of it s functioning;  5. In the case of non -conformity of the medical device to the requirements of this Law 
and to the legislation developed in it s application, the State Agency of Medical Devices 
commences a supervising procedure for the purpose of withdrawing this device from the 
market, inhibition or restriction of launching it and ma king it available. The State Agency 
of Medical Devices immediately informs the European Commission and the accredited 
authorities of the European Economical Zone for the commencement of a s upervising 
procedure and for it s performance and result.   
6.  When  relevant, the State Agency of Medical Devices reserves the right to, within two 
years from launching a medical device with the CE mark, defined in article “The 
notification of launching the medical devices and the provision of information on the 
medical d evices that are in the market” of this Law, to request a report from the 
manufacturer providing the information on the devices taken from the market.   
7.  The State Agency of Medical Devices reserves the right to obligate any person 
launching a medical de vice, to inform the public on the risks relating to this device or to 
provide that information through the person responsible.  
8. The method of report utilised by the persons that perform the supervision is approved 
by the Minister of Health.  
 
Article 26  
The Inspection of the Conformity of Medical Devices to the Requirements  
 
1. In the framework of state supervision, the State Agency of Medical Devices reserves 
the right, with the scope of inspecting the conform ity of the medical device or it s parts 
that enter the market, with a reasonable fee, to take the necessary amount of medical 
devices or their parts from the manufacturer of the medical device or the person that 
launches them  and in certain cases, order the assessment services for the inspection of 
conformity of the medical devices or their parts.  
2. In cases of suspicion, which  can be evidenced, the State Agency of Medical Devices 
reserves the right to prohibit the launch of a medical device for the period of time 
necessary to perform a final contro l of the conformity of the medical device to meet the 
stated requirements.  
3.  Based on the inspection result of a medical device, the State Agency of medical 
Devices reserves the right to request:  
a) the provision of additional information regarding the  utilisation of the device 
and the risks relating to the launch;  
b) that the manufacturer, his authorised representative or the person launching the 
device, to inform the users within a set period of time regarding the risks relating 
to the use of the med ical device launched and the possibility of eliminating this 
risk;  
c) the withdrawal of a medical device from the market evidenced to be harmful, 
the banning of the product’s advertisement and depending on the situation, the 
elimination of the medical dev ice.  
4.  If the expert notices that the medical device is conforming,  the State Agency of 
Medical Devices meets all expenses of the service assessment service assigned for the 
inspection of the medical device, returns the medical device or compensates for  the direct 
financial damage. If the expert notices that the device is not conforming , the expenses of the assessment service are met by the manufacturer, the authorised representative or the 
person launching the device, taking into consideration the guida nce issued by the State 
Agency of Medical Devices that should include, as an appendix, a copy of the document 
as proof for the expenses of the person that has conducted the assessment service.  
5. The method of report utilised by the persons performing the  inspection is approved by 
the Minister of Health.  
 
 
 
Article 27  
Sanctions  
 
1. Infringement of articles 6, 7 and of this law, when they do not constitute an 
offence, constitute as administrative crime and is punishable by a fine of up to 
500 000 L.     
2. The r esponsible authority for the enforcement and execution of the penalty is the 
State Agency of Medical Devices.  
3. The procedures for the enforcement of the penalty and for the appeal are regulated 
in accordance with Law No. 7694, dated 7 April 1993 “On Adminis trative 
Crime”.  
 
 
 
 
 
 
 
 
CHAPTER VI  
 
FINAL PROVISIONS  
 
Article 28  
Issue of Regulations  
 
1. The Council of Ministers has a responsibility to issue regulations in application to 
article 7 clause 2, article 9 clause 6, article 10 clause 2, article 11 clause 3 and  
article 16 clause 2 within six months from the enforcement date of this law.  
2. The Ministry of Health has a responsibility to issue regulations in application to 
article 5 clause b, 14 clause 5, article 19 clause 8, article 25 clause 8 and article 26 
claus e 5 within six months from the enforcement date of this law.  
 
 
 
Article 29  The Utilisation of Medical Devices Launched Prior to the Enforcement Date of this 
Law  
 
The medical devices that are launched in compliance with the procedure in force at the 
time of  the enforcement of this law and that are considered to be safe, may still be used 
until the end of their expected service life.  
 
Article 30  
 
Date of Enforcement  
 
This law will be enf orced fifteen days following it s publication in the “Official Journal”.